NEW YORK, Aug. 6, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in SeaStar Medical Holding Corporation ("SeaStar Medical" or the "Company") (NASDAQ: ICU) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of SeaStar Medical investors who were adversely affected by alleged securities fraud between October 31, 2022 and March 26, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra- ...

NEW YORK, Aug. 5, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of SeaStar Medical Holding Corporation (NASDAQ: ICU). Shareholders who purchased shares of ICU during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/seastar-medical-loss-submission-form/?id=93549&from=4 CLASS PERIOD: O ...

Core Viewpoint - SeaStar Medical Holding Corporation is facing a federal securities class action lawsuit due to allegations of making false or misleading statements regarding its compliance controls and financial reporting, leading to a significant restatement of its financial statements [2][3][4]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against SeaStar and has set a deadline of September 6, 2024, for investors to seek the role of lead plaintiff in the class action [2]. - The lawsuit alleges that SeaStar and its executives violated federal securities laws by failing to disclose deficiencies in compliance controls related to the HDE Application and overstating the regulatory prospects of the SCD [3]. Group 2: Financial Restatement - On March 27, 2024, SeaStar announced it would restate its financial statements for the fiscal year ended December 31, 2022, and interim periods ended March 31, 2023, June 30, 2023, and September 30, 2023, due to issues with the accounting treatment of certain financial instruments [4]. - The CEO stated that the restatement is not expected to materially impact the company's operations or cash position, but is related to non-cash accounting items [4]. Group 3: Market Reaction - Following the announcement of the restatement, SeaStar's stock price fell by $0.04 per share, or 5.41%, closing at $0.70 per share on March 27, 2024 [8].

If you are a shareholder who purchased or otherwise acquired SeaStar securities during the Class Period, you have until September 6, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained atwww.pomerantzlaw.com. To discuss this action, contact Danielle Peyton atnewaction@pomlaw.comor 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by email are encouraged to include their mailing address, telephone number, and the number of shares ...

Nestor Jaramillo, President and CEO of Nuwellis, shared his thoughts on this milestone: "We are thrilled to introduce QUELIMMUNE to critically ill pediatric patients in need. This marks a significant step forward in Nuwellis' mission to execute our pediatric business development strategy. By partnering with SeaStar Medical, we are committed to bringing this groundbreaking therapy to U.S. healthcare providers, offering new hope to children suffering from severe immune system reactions." About Nuwellis Dr. St ...

NEW YORK, July 25, 2024 /PRNewswire/ -- So what: If you purchased SeaStar securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. Details of the case: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) SeaStar and/or Legacy SeaStar had deficient compliance controls and procedures related to the HDE Application; (2) ...

NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents inves ...

Company Overview - SeaStar Medical Holding Corporation has successfully treated its first patient with QUELIMMUNE™, an FDA-approved therapy for acute kidney injury (AKI) in pediatric patients [1][2] - The company aims to provide widespread access to QUELIMMUNE, which has shown potential to save lives and reduce dialysis dependency in severely ill children [2] Product Details - QUELIMMUNE is a patented cell-directed extracorporeal therapy that targets activated proinflammatory neutrophils and monocytes, restoring them to a reparative state [4] - The treatment process takes about 15 minutes and requires a full course of therapy lasting three to seven days, with the SCD-PED cartridge replaced every 24 hours [4] Clinical Impact - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a mortality rate of around 50% [2] - Clinical trials indicate that children treated with QUELIMMUNE had a 77% survival rate without dialysis dependency at 60 days, with no serious adverse events reported [2] Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [5] - The company is currently enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial, expanding its therapeutic reach [5] Company Mission - SeaStar Medical is focused on redefining extracorporeal therapies to mitigate excessive inflammation's impact on vital organs, aiming to provide life-saving solutions for critically ill patients [6]

Core Viewpoint - SeaStar Medical has successfully treated its first patient with QUELIMMUNE, a therapy for acute kidney injury (AKI) in pediatric patients, meeting FDA requirements for timely treatment [5]. Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing cell-directed extracorporeal therapies to mitigate excessive inflammation in critically ill patients [8]. - The company’s first product, QUELIMMUNE, is a Selective Cytopheretic Device (SCD) that targets activated proinflammatory cells to restore them to a reparative state [7]. Product Details - QUELIMMUNE is FDA-approved for treating pediatric patients with AKI who weigh 10 kilograms or more and require kidney replacement therapy [5]. - The treatment process involves using a disposable SCD-PED cartridge connected to an existing hemodialysis system, with an average treatment duration of three to seven days [7]. - Clinical trials indicate that children treated with QUELIMMUNE have a 77% survival rate without dialysis dependency at 60 days post-treatment, with no serious device-related adverse events reported [10]. Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [3]. - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a high mortality rate of around 50% [10].

Core Viewpoint - SeaStar Medical Holding Corporation is facing legal challenges due to alleged misleading statements and deficiencies in compliance related to its Humanitarian Device Exemption application, leading to significant stock price declines and potential financial restatements [5][9]. Group 1: Legal and Financial Implications - A class action lawsuit has been filed on behalf of investors who purchased SeaStar securities between October 31, 2022, and March 26, 2024, with a deadline of September 6, 2024, to file a lead plaintiff motion [4]. - SeaStar's stock price fell by $0.04, or 4.8%, closing at $0.71 per share on March 27, 2024, following the announcement of the need to restate financial statements [2]. - The company announced on March 27, 2024, that it would restate financial statements for fiscal year 2022 and the first three quarters of fiscal year 2023 due to complex financial instruments requiring different accounting treatment [5]. Group 2: Regulatory Challenges - On May 9, 2023, SeaStar disclosed that the FDA rejected its Humanitarian Device Exemption application for its pediatric Selective Cytopheretic Device, citing that the application was not approvable in its current form [8]. - The complaint alleges that SeaStar had deficient compliance controls related to the HDE application and that the FDA was unlikely to approve it in its present form, which was not disclosed to investors [9]. Group 3: Stock Performance - Following the FDA rejection news, SeaStar's stock price dropped by $0.77, or 39.7%, closing at $1.17 per share on May 10, 2023, indicating significant investor injury [11].